Pain Medications and Pregnancy

January 9, 2015

Careful review of the literature found data too limited to change recommendations about use of pain medications during pregnancy.

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As a result of recent reports raising concerns about the safety of prescription and over-the-counter (OTC) pain medicines used during pregnancy, the US Food and Drug Administration evaluated research studies published in the medical literature and determined they are too limited to make any recommendations at this time.

The agency recommends that clinicians:

Talk with each patient about the benefits and risks of analgesic use during pregnancy, which may differ among patients and by treatment indication.

Continue to follow the existing recommendations in current drug labels regarding the use of analgesics during pregnancy.

Current drug labels state that nonsteroidal anti-inflammatory drugs (NSAIDs) should not be used by pregnant women in their third trimester of pregnancy because of the risk of premature closure of the ductus arteriosus in the fetus.

Report adverse events involving analgesics to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.

Why the Review

Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother.1 Medicines including NSAIDs, opioids, and acetaminophen can help treat severe and persistent pain. However, it is important to carefully weigh the benefits and risks of using prescription and OTC pain medicines during pregnancy, noted the agency.

The published studies reviewed by the FDA reported on the potential risks associated with the following 3 types of pain medicines used during pregnancy:

Prescription NSAIDs and the risk of miscarriage in the first half of pregnancy.2-6 Examples of prescription NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib.

Opioids, which are available only by prescription, and the risk of birth defects of the brain, spine, or spinal cord in babies born to women who took these products during the first trimester of pregnancy.7,8 Examples of opioids include oxycodone, hydrocodone, hydromorphone, morphine, and codeine.

Acetaminophen in both OTC and prescription products and the risk of attention deficit hyperactivity disorder (ADHD) in children born to women who took this medicine at any time during pregnancy.9 Acetaminophen is a common pain reducer and fever reducer found in hundreds of medicines including those used for colds, flu, allergies, and sleep.

“We found all of the studies we reviewed to have potential limitations in their designs; sometimes the accumulated studies on a topic contained conflicting results that prevented us from drawing reliable conclusions. As a result, our recommendations on how pain medicines are used during pregnancy will remain the same at this time,” noted the agency.

Warn Pregnant Patient About Risks

Clinicians should remind pregnant women to consult with their health care professional before taking any prescription or OTC medicine. Women taking pain medicines who are considering becoming pregnant should also consult with their health care professionals to discuss the risks and benefits of pain medicine use. "Health care professionals should continue to follow the recommendations in the drug labels when prescribing pain medicines to pregnant patients," noted the agency.

The agency will continue to monitor and evaluate the use of pain medicines during pregnancy and will update the public as new safety information becomes available.

Facts About Pain Medicines During Pregnancy

• A variety of medicines are prescribed to treat pain, including severe and persistent pain in pregnant women. These include nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen.

• NSAIDs are available by prescription and over-the-counter (OTC). They are used to relieve fever and pain, such as those associated with headaches, colds, flu, and arthritis. Examples of prescription NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib. Ibuprofen and naproxen are also available OTC at lower strengths. Findings from two U.S. studies indicate that approximately 18-25% of pregnancies are exposed to OTC ibuprofen and 4% of pregnancies are exposed to OTC naproxen.10

• During each trimester of pregnancy, approximately 6% of pregnant women in the US are exposed to opioids.11

• Acetaminophen is used in prescription combination products to reduce pain and in OTC products to reduce pain and fever. Acetaminophen is found in hundreds of medicines including those used for colds, flu, allergies, and sleep. Findings from two U.S. studies indicate that 65-70% of pregnant U.S. women reported using acetaminophen anytime during pregnancy.10

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